The use of ramucirumab plus paclitaxel is safe and effective as a second-line option for Asian patients with advanced gastric or gastroesophageal junction adenocarcinoma, according to a study published in Lancet Gastroenteroloy Hepatology.

RAINBOW-Asia, a phase 3 trial, included Asian patients who had disease progression of gastric or gastroesophageal junction adenocarcinoma within 4 months of receiving platinum-fluoropyrimidine-based therapy (ClinicalTrials.gov Identifier: NCT02898077).  Patients were randomly assigned 2:1 to receive intravenous ramucirumab 8 mg/kg (n=294) or placebo (n=146) on days 1 and 15 of a 28-day cycle. All patients also received intravenous paclitaxel 80 mg/m2 on days 1, 8, and 15 of the cycle.

The purpose of the study was not to show efficacy of ramucirumab plus paclitaxel over paclitaxel monotherapy but to show consistency of results from the previously published RAINBOW study in an Asian population. The co-primary endpoints were overall survival, indicating time of randomization to time of death, and progression-free survival, indicating time of randomization to time of disease progression or death.


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In total, 440 patients were included in the study; median patient age was 57.5 years, 68% were men, and 89% were Chinese.  

Overall survival was longer in patients who received ramucirumab plus paclitaxel compared with patients in the placebo plus paclitaxel group at 8.71 and 7.92 months, respectively (hazard ratio [HR], 0.963; 95% CI, 0.771-1.203; P =.7426). Progression-free survival was also improved in the ramucirumab group (4.14 months) compared with placebo (3.15 months), with a stratified HR of 0.765 (95% CI, 0.613-0.955; P =.0184). Neither difference was statistically significant between groups but was consistent with results from the previous RAINBOW trial.

Investigators note their study design lacks biomarker research and data on histological subtype of gastric cancers.

Researchers believe that ramucirumab plus paclitaxel is an effective and safe second-line treatment option for Asian patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Disclosure: The authors declared affiliations with biotech, pharmaceutical, and/or device companies. Pleases see the original reference for a full list of author disclosures.

Reference

Xu RH, Zhang Y, Pan H, et al. Efficacy and safety of weekly paclitaxel with or without ramucirumab as second-line therapy for the treatment of advanced gastric or gastroesophageal junction adenocarcinoma (RAINBOW-Asia): a randomised, multicentre, double-blind, phase 3 trial. Lancet Gastroenterol Hepatol. 2021;6(12):1015-1024. doi: 10.1016/S2468-1253(21)00313-7